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CFT1946

Phase 1

Solid Tumors | Small molecule | Oncology |C4 Therapeutics, Inc.|Trials Updated: Nov 21, 2025

CFT1946 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Dec 2022

CFT1946 target and mechanism

Molecular targetBRAF V600
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment89

FDA Designations

No designations recorded

CFT1946 clinical trials

CFT1946 · 1 trial · 5 indications

Phase 1 1
NCT05668585A Study to Characterize the Safety, Tolerability, and Preliminary Efficacy of CFT1946 as Monotherapy and Combination Therapy in Subjects With BRAF V600 Mutant Solid TumorsSolid Tumors
COMPLETED89 Analytics
PHASE1COMPLETED
A Study to Characterize the Safety, Tolerability, and Preliminary Efficacy of CFT1946 as Monotherapy and Combination Therapy in Subjects With BRAF V600 Mutant Solid Tumors
Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Frequency and severity of AEs and SAEs
From enrollment until 30 days after completion of study treatment

Phase 1

Incidence of dose limiting toxicities (DLTs)
From enrollment until 28 days after first dose

Phase 1

Number of subjects with changes between baseline and post-baseline safety assessments based on safety laboratory results graded by CTCAE v5.0
From enrollment until 30 days after completion of study treatment

Phase 1

Frequency of dose interruptions and dose reductions
From enrollment until 30 days after completion of study treatment

Phase 1

Frequency of AEs leading to discontinuation of study treatment(s)
From enrollment until 30 days after completion of study treatment

Phase 1

Overall response rate (ORR)
Up to approximately 43 months

Phase 2 only according to RECIST v1.1 criteria

Disease control rate (DCR) at 3, 6, and 12 months
Up to 12 months

Phase 2

Duration of Response (DOR)
Up to approximately 43 months

Phase 2

Secondary Endpoints

Frequency and severity of AEs and SAEs
From enrollment until 30 days after completion of study treatment
Number of subjects with changes between baseline and post-baseline safety assessments based on safety laboratory results graded by CTCAE v5.0
From enrollment until 30 days after completion of study treatment
Frequency of dose interruptions and dose reductions
From enrollment until 30 days after completion of study treatment
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase 1: Arm A: CFT1946EXPERIMENTALApproximately 40 subjects with V600 Solid Tumors (non-CNS) (post BRAF inhibitor for NSCLC, CRC, melanoma, ATC)
Phase 1: Arm B: CFT1946 + trametinibEXPERIMENTALApproximately 28 subjects with V600 Solid Tumors (non-CNS) (post BRAF inhibitor for NSCLC, CRC, melanoma)
Phase 2: Arm A1: CFT1946EXPERIMENTALApproximately 30 subjects with V600 melanoma or NSCLC (post BRAF inhibitor)
Phase 2: Arm B1: CFT1946 + trametinibEXPERIMENTALApproximately 20 subjects with V600 melanoma or NSCLC (post BRAF Inhibitor)
Phase 1: Arm C: CFT1946 + cetuximabEXPERIMENTALApproximately 30 subjects with CRC (post BRAF inhibitor)
Phase 2: Arm C1: CFT1946 + cetuximabEXPERIMENTALApproximately 40 subjects with CRC (post BRAF inhibitor)

Interventions

NameTypeDescription
CFT1946DRUGSpecified oral dose on specified day
TrametinibDRUGSpecified oral dose on specified day
CetuximabDRUGSpecified intravenous dose on specified day
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion Criteria: 1. Subject (or legally authorized representative, where applicable) is willing and able to provide signed informed consent and can follow protocol requirements 2. Subject is ≥18 years of age at time of informed consent 3. Eastern Cooperative Oncology Group performance status of ...

Countries:United StatesFranceGermanySpainUnited Kingdom
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Competitive Landscape -Other Solid Tumors 10 trials (matched to "Solid Tumors")

Frequently asked questions about CFT1946

What is CFT1946?

CFT1946 is an investigational small molecule developed by C4 Therapeutics, Inc. (ticker CCCC) for the treatment of BRAF V600 mutant solid tumors. It is being studied as both a monotherapy and in combination therapy in adult patients with cancers including melanoma, NSCLC, CRC, and ATC.

What is CFT1946 used for in solid tumors?

CFT1946 is being developed for BRAF V600 mutant solid tumors. The Phase 1 study enrolled patients with melanoma, non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and anaplastic thyroid cancer (ATC). It is investigational and has not been approved for any indication.

What does CFT1946 target?

CFT1946 targets BRAF V600, a mutant form of the BRAF protein. It is a small molecule designed to act against tumors carrying this specific mutation. The Phase 1 trial was biomarker-selected, enrolling only patients whose tumors harbor the BRAF V600 mutation.

Who is developing CFT1946?

CFT1946 is being developed by C4 Therapeutics, Inc., which trades on the Nasdaq under the ticker CCCC. The company is the sponsor of the clinical program evaluating CFT1946 in BRAF V600 mutant solid tumors.

What phase is CFT1946 in?

CFT1946 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA or any other regulatory authority. The Phase 1 trial has been completed, and no active trials are currently listed for this asset.

What clinical trials is CFT1946 in?

CFT1946 was evaluated in one Phase 1 trial, NCT05668585, titled a study to characterize the safety, tolerability, and preliminary efficacy of CFT1946 as monotherapy and combination therapy in subjects with BRAF V600 mutant solid tumors. The trial enrolled 89 patients across the United States, France, Germany, Spain, and the United Kingdom, and is completed.